The IFPAC annual meeting on advancing the understanding and control of manufacturing processes using process analytical technology will be held Feb. 11-14, 2018.

The contract manufacturing company has completed construction on a new aseptic fill/finish facility in Wuxi, China.

The agency published draft guidance on good practices for submitting abbreviated new drug applications.

PharMEDium Services, LLC voluntarily recalled some lots of product because of a lack of sterility assurance.

Bio/pharma professionals manage expectations amid industry uncertainty.

Will business decisions and drug pricing policies help or hinder science and drug approval advances in 2018?

The companies have entered an agreement involving assay development and the manufacturing of kits supporting biomarker research programs.

The biotechnology company has filed for FDA approval of a new plasma manufacturing facility in Covington, GA, to support its immunology franchise.

The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.

Mallinckrodt has agreed to acquire biopharmaceutical company Sucampo Pharmaceuticals for $18 per share, or a transaction value of approximately $1.2 billion.

Roche has agreed to acquire Ignyta, an oncology company specializing in precision medicines, in an all-cash transaction valued at $1.7 billion.

New tax legislation may result in savings for biopharma companies.

The company is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial because of glass particles found in a vial.

FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.

FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.

MilliporeSigma will collaborate with IPS and G-CON to offer end-to-end, turnkey, modular MAb manufacturing.

BioTek Instruments has released a second edition of its BioSpa software that now offers users a simplified but effective interface for kinetic imaging or detection workflows.

Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, have filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.

The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.

EMA recommends suspending the marketing of modified- or prolonged-released products containing paracetamol due to a difficulty in managing overdose.

The European Commission has closed its infringement procedure against Roche after the company completed remedial actions.

The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.

Cycle and Aprecia will use Aprecia's 3DP Technology to improve rare disease drug formulations.

The draft guidance provides guidance on the development of drugs and biologics in which a nanomaterial is present in the finished dosage form.

The agency has proposed a risk-based enforcement approach to protecting patients against unproven homeopathic drugs.